Liquidia Technologies said that it has received a complete response letter in response to its NDA for LIQ861 treprostinil inhalation powder for the treatment of pulmonary arterial hypertension. The FDA accepted the 505(b)(2) NDA for review in April 2020. According to Liquidia, the letter cites "the need for additional information and clarification on chemistry, … [Read more...] about Liquidia gets CRL for LIQ861 treprostinil DPI
News
Verona Pharma gets up to $30 million in debt financing for pre-commercialization activities for nebulized ensifentrine
Verona Pharma announced that it has secured up to $30 million in debt financing facility from Silicon Valley Bank for pre-commercialization activities related to the company's nebulized ensifentrine, which is in Phase 3 development for the treatment of COPD. The credit line allows Verona to borrow $5 million at closing, then a further $10 million through mid-2022 if … [Read more...] about Verona Pharma gets up to $30 million in debt financing for pre-commercialization activities for nebulized ensifentrine
Synairgen turns to Parexel for help with Phase 3 trial of inhaled interferon beta for COVID-19
Parexel announced that Synairgen has signed a collaboration agreement with Parexel Biotech for a Phase 3 trial of Synairgen's SNG001 nebulized interferon-beta-1a for the treatment of COVID-19. In July 2020, Synairgen announced positive results from a Phase 2 trial of SNG001 in COVID-19 patients hospitalized in the UK. The Phase 3 SG018 trial is expected to enroll 900 … [Read more...] about Synairgen turns to Parexel for help with Phase 3 trial of inhaled interferon beta for COVID-19
Monaghan Medical to move ahead with sales of Adherium’s Hailie inhaler monitoring system in US respiratory centers
Adherium has announced that Monaghan Medical is set to begin a pilot program to launch Adherium's Hailie inhaler monitoring platform in eight US respiratory centers by the end of the first quarter of 2021, with more centers expected to be added later in the year. The companies announced their partnership in April 2020 and now say that they have completed training and … [Read more...] about Monaghan Medical to move ahead with sales of Adherium’s Hailie inhaler monitoring system in US respiratory centers
PureIMS names Bram van Dijck as CEO
Dutch DPI developer PureIMS has announced the appointment of Bram van Dijck as its new Chief Executive Officer, succeeding Reinier Schwietert, who is stepping down as CEO but will remain with the company. Van Dijck was most recently Global Head Portfolio Management at the Grünenthal Group and has worked in executive positions at numerous pharmaceutical companies, … [Read more...] about PureIMS names Bram van Dijck as CEO
Marinomed announces planned Phase 4 trial of Carregelose nasal spray for COVID-19
Marinomed Biotech has announced plans for a Phase 4 trial of Carragelose iota-carrageenan nasal spray in healthcare professionals in contact with COVID-19 patients to study the ability of the nasal spray to reduce symptoms of viral respiratory infections, including SARS-CoV-2. The nasal spray is marketed as "Coldmaris Pro" in Austria, where the study will take … [Read more...] about Marinomed announces planned Phase 4 trial of Carregelose nasal spray for COVID-19
FDA issues new product specific guidances for diazepam nasal spray, epinephrine MDI, and tiotropium bromide SMI
The batch of new product specific guidances published by the FDA in November 2020 include guidances for generic OINDPs referencing Valtoco diazepam nasal spray, Primatene Mist epinephrine MDI, and Spiriva Respimat tiotropium bromide SMI. The agency approved Valtoco for the treatment of seizure clusters in January 2020. After a lengthy effort to reformulate … [Read more...] about FDA issues new product specific guidances for diazepam nasal spray, epinephrine MDI, and tiotropium bromide SMI
US Court of Appeals upholds judgment against GSK for infringing on Vectura patents
According to inhalation CDMO Vectura, the United States Court of Appeals for the Federal Circuit has upheld a ruling by the District Court of Delaware against GlaxoSmithKline for infringing on a Vectura patent and has denied GSK a new trial. If GSK wants to ask to have the case heard again, it has 30 days to file a petition. In May 2019, a jury found that GSK … [Read more...] about US Court of Appeals upholds judgment against GSK for infringing on Vectura patents
Zeteo Biomedical to provide nasal delivery technology for Iowa State University vaccine against SARS-CoV-2
Zeteo Biomedical said that the company will supply its ZEOx2 nasal delivery system and unit dose packaging for use with a shelf-stable SARS-CoV-2 vaccine in development at the Nanovaccine Institute at Iowa State University. Zeteo is already working with Iowa State on an intranasal universal flu vaccine. The ZEOx2 platform can be used for intranasal delivery of dry … [Read more...] about Zeteo Biomedical to provide nasal delivery technology for Iowa State University vaccine against SARS-CoV-2
Milestone initiates new Phase 3 trial of etripamil nasal spray for PSVT
Milestone Pharmaceuticals has announced the initiation of the RAPID Phase 3 trial of etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). A previous Phase 3 trial, NODE-301, failed to meet its primary endpoint. In July 2020, Milestone announced that it had reached an agreement with the FDA on the design of the RAPID study … [Read more...] about Milestone initiates new Phase 3 trial of etripamil nasal spray for PSVT